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临床试验/NCT00164346
NCT00164346已完成1 期

Neurocognitive Habilitation for Children With FAS/ARND

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
2
主要终点
foster care placement stability

研究概览

简要总结

Children will receive comprehensive evaluations through the Children's Research Triangle (CRT) clinical program. The assessment for the child will be in accordance with the protocol developed by Astley and Clarren as performed by one of the clinic pediatricians and final diagnosis will be according to Institute of Medicine (IOM) criteria. Children will be randomized into either a Treatment or Control group. The Treatment group will receive (in addition to standard referrals) neurocognitive habilitation and psychotherapy services as well as parent psychoeducation. The Control group will be referred for intervention through existing community and school-based agencies.

详细描述

Neurocognitive habilitation, based on the traumatic brain injury literature for teaching compensatory skills, will be the primary intervention. Interventions will be individually designed and delivered through individual therapy sessions. Audiotapes will augment the sessions to facilitate implementation of strategies in the home environment. Didactic therapy will be used to foster appropriate interactions and relationships between parent and child. Children will participate in 8-week group sessions that will include neurocognitive exercises, homework sessions, and possibly group psychotherapy. An educational specialist will provide school and legal advocacy services as well as observations of the child in the classroom that could lead to educational modifications.

Parent Component: Family education programs and parent support groups using psychoeducational approaches will be the means of intervening with parent behaviors. Parents will be instructed on becoming advocates for their child. Groups of 8 to 12 parents will meet for one 2-hour session per week for 8 weeks. Each session will include:

  1. neurocognitive exercises (relaxation);
  2. specific topic discussions; and
  3. general support.

During the last hour of the final two weeks of the program, parent and children will be combined to practice learned techniques. Children and parents will participate in monthly "booster" sessions.

Evaluation Plan: Treatment and control groups will be compared using pre- and post-test measures. Post-tests will be at the conclusion of the intervention, as well as at 12, and 24-month follow-ups. Process and outcome measures will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6 to 12 years
  • Children in the care of Illinois foster care

排除标准

  • 未提供

结局指标

主要结局

foster care placement stability

次要结局

未报告次要终点

研究者

研究点 (2)

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